Manufacturer

Phadia US Inc

9 recalls in our database name Phadia US Inc as the manufacturing or recalling firm.

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2023-07-05

Of the 9 recalls from Phadia US Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

ModerateFDA (Devices)·Z-2041-2023·2023-07-05
Phadia 2500EE diagnostic instrument recalled for measurement inaccuracy
Phadia US Inc is recalling the Phadia 2500EE diagnostic instrument. The device produces higher reported results compared to the baseline Phadia 250 instrument.
Product
Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2040-2023·2023-07-05
Diagnostic Test Well Shows Inconsistent Results on Phadia 2500EE
The EliA GliadinDP IgG test well produces higher reported results when used on the Phadia 2500EE instrument compared to the Phadia 250, potentially causing diagnostic inaccuracies. Phadia US Inc is recalling 568 units distributed in California, New Jersey, and Michigan.
Product
EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac di
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1107-2021·2021-02-17
Phadia Recalls EliA dsDNA Well Kits Due to Potential False Positive Results
Phadia US Inc is recalling EliA dsDNA Well kits because decreased positive control values may cause false positive test results for systemic lupus erythematosus.
Product
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1312-2018·2018-04-11
Phadia Recalls ImmunoCAP Allergen c5 Ampicilloyl Test Kits
Phadia US Inc is recalling ImmunoCAP Allergen c5, Ampicilloyl test kits because stability specifications were not met.
Product
ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1313-2018·2018-04-11
Phadia Recalls ImmunoCAP Allergen c6 Amoxicilloyl Due to Stability Failures
Phadia US Inc is recalling 950 units of ImmunoCAP Allergen c6, Amoxicilloyl because the product failed to meet stability specifications.
Product
ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0387-2018·2018-01-24
Phadia 1000 Instrument Recalled Due to Retry Command Malfunction
Phadia US Inc is recalling 70 Phadia 1000 Instruments nationwide because a malfunctioning Retry command may cause solution shortages and affect test results.
Product
Phadia 1000 Instrument, Article Number 12-3800-01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1253-2017·2017-03-08
Phadia Recalls EliA Sample Diluent Due to Liquid Level Detection Issues
Phadia US Inc is recalling EliA Sample Diluent because liquid level detection problems in Phadia 250 instruments caused erroneous test results.
Product
EliA Sample Diluent, Article number, 83-1023-01
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0947-2015·2015-01-21
Phadia 1000 Instrument Recalled for Rack Sequencing Error
Phadia US Inc is recalling 146 Phadia 1000 instruments due to a software error that may cause sample ID and test result mismatches.
Product
Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utili
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2285-2012·2012-09-05
Phadia Varelisa Cardiolipin IgM Test Kits Recalled for Elevated Results
Phadia US Inc is recalling Varelisa Cardiolipin IgM test kits because a material change combined with a prior instruction to omit a pre-wash step caused elevated assay results.
Product
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Category
Medical Device
Distribution
Distributed nationwide